Roflumilast/donepezil to reverse scopolamine induced cognitive defecit

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled, five-period, cross-over study to evaluate the effects of single oral administrations of roflumilast in combination with donepezil on reversing scopolamine induced deficits in psychomotor and cognitive function in healthy adults.

• IRAS ID

  110759

• Contact name

  Arpeat Kaviya

• Sponsor organisation

  Nycomed a Takeda Company

• Eudract number

  2012-002089-11

• Research summary

  Alzheimers Disease a form of dementia where there is a loss of brain function over time. It usually affects people over the age of 65 and causes impairment of mental processes and symptoms which include confusion, irritability and aggression, mood swings, trouble with language and long-term memory loss. There is no cure for this disease. Drugs such as donepezil (Aricept?½) are available which provide modest symptomatic treatment to a portion of patients but benefits are usually short-lived. fluilast may be useful as a potential treatment of Alzheimers Disease and this is the study drug which we are investigating in this study. A drug called scopolamine will be given in this study to mimic the symptoms (i.e impairment of mental processes) seen in Alzheimer??s Disease and we will see if fluilast can reverse those symptoms when given as 3 different doses in combination with donepezil. A computer program called the Cambridge Neuropsychological Test Automated Battery (Cantab Test) will test how the scopolamine affects the volunteer's mental processes and assess whether the study drug improves this.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1441

• Date of REC Opinion

  19 Oct 2012

• REC opinion

  Favourable Opinion